BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2874480 · Received December 14, 2012

    Report

    Report Number
    3003775027-2012-00064
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 19, 2012
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCTS: GUIDE WIRE: HI-TORQUE WHISPER 190 CM; DILATATION CATHETER: MINI TREK. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI (B)(4); HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE HI-TORQUE WHISPER AND MINI TREK, REFERENCED ARE BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EXP. DATE REPORTED AS (B)(6) 2014. INVESTIGATION OF THE RETURNED PROWATER GUIDEWIRE REVEALED THAT THE TIP WAS ROUNDLY DEFORMED, HOWEVER NO COIL STRETCH WAS OBSERVED. SLIGHT BENDS WERE FOUND WITH THE SHAFT AT 23CM FROM TIP END AND 24CM FROM PROXIMAL END. THESE WERE CONSIDERED TO HAVE OCCURRED ALONG WITH THE USE OF THE DEVICE IN THE PROCEDURE. TACTILE INSPECTION OF THE COIL SECTION WAS PERFORMED BUT NO NOTABLE IRREGULARITY WAS NOTICED. INSPECTION OF THE HYDROPHILIC POLYMER COATING WITH DYE-CHEMICAL REVEALED FAINT DYE REACTION FOR MOST OF THE COIL SECTION, SUGGESTING THAT THE HYDROPHILIC POLYMER WAS ABRADED AND REMOVED. THE COIL OUTER DIAMETER DIMENSION WAS INSPECTED AND IT MET THE PRODUCT SPECIFICATIONS WITH NO IRREGULARITY. THE ABRASION OF THE HYDROPHILIC POLYMER COATING IS CONSIDERED TO HAVE OCCURRED WHEN THE SURFACE OF THE GUIDEWIRE WAS SEVERED DURING USE IN THE PROCEDURE, THIS CAN BE CONSIDERED AS A NORMAL EVENT. THE DEFORMATION OBSERVED WITH THE RETURNED GUIDEWIRE IS CONSIDERED TO BE THE RESULT OF USE OF THE DEVICE IN THE PROCEDURE. NO NOTABLE IRREGULARITY WAS FOUND WITH THE RETURNED GUIDEWIRE. THE CAUSE OF THE REPORTED RESISTANCE FELT WITH THE BALLOON DILATATION CATHETER COULD NOT BE IDENTIFIED FROM THE INVESTIGATION OF THE RETURNED GUIDEWIRE. THE LOT HISTORY REVIEW, CONDUCTED BASED ON THE LOT NUMBER OBTAINED FROM THE RETURNED PRODUCT LABEL, REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORT THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, FIRST OBTUSE MARGINAL OF THE CIRCUMFLEX ARTERY, THE ASAHI PROWATER GUIDE WIRE WAS POSITIONED AND THE 2.0 X 12 MM MINI TREK OTW BALLOON DILATATION CATHETER (BDC) MET RESISTANCE DURING ADVANCING AND REMOVAL BUT THE BDC WAS INFLATED AND DEFLATED THREE TIMES AT 8 ATMOSPHERE (ATM) WITHOUT ISSUE. THE BDC WAS LEFT IN POSITION AND THE PROWATER WAS REMOVED AND A WHISPER GUIDE WIRE WAS ADVANCED AND POSITIONED. IT WAS NOTED THAT ALTHOUGH IMPROVED, THERE WAS STILL RESISTANCE NOTED WITH THE MINI TREK OTW BDC. THE PROCEDURE WAS COMPLETED AND THE BDC AND GUIDE WIRE WERE REMOVED AS A SYSTEM FROM THE ANATOMY WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 110309A121

    Patients

    Seq Age Sex Outcome Treatment
    1